Viewing Study NCT01440036



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Study NCT ID: NCT01440036
Status: UNKNOWN
Last Update Posted: 2011-12-16
First Post: 2011-09-22

Brief Title: The Correlation Between the Enzyme Paraoxigenase 1 PON1 to Carotid Artery Atheromatous Plaque
Sponsor: Ziv Hospital
Organization: Ziv Hospital

Study Overview

Official Title: The Correlation Between the Enzyme Paraoxigenase 1 PON1 to Carotid Artery Atheromatous Plaque
Status: UNKNOWN
Status Verified Date: 2011-12
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The objective of the research is to examine the hypothesis that the enzyme paraoxygenase 1 PON1 can influence carotid arterys atherosclerotic plaque content and stability and its relation to plasmas enzyme concentration
Detailed Description: Atherosclerosis is a major risk factor for morbidity and mortality in the western world It is characterized by the accumulation of fat cholesterol in the arterial wall creation of the atheromatous plagues and the creation of arterial stenosis and occlusion The cellular content of theses plaques include fibroblasts endothelial cells smooth muscle cells macrophages and lipids phospholipids cholesterol oxysterols and fatty acids Lipids penetration from the blood stream collaborates different proteins including the anti-atherogenic enzyme - paraoxygenase 1 - PON1 This enzyme has many ani-atherogenic activities eg Protection from oxygenation and increase of cholesterol efflux from macrophages by HDL Although the enzyme has a verity of substrates and known anti-atherogenous function its mechanism is still vogue The enzymes accumulation rate is the function of the advancement of the fatty strike towards advanced lesion There is evidence that the presence accumulation and activity of the PON1 within the plaque is a defense mechanism against atherosclerosis development The assumption to be proved is that PON1 can control plaques content and influence its atherogenous factors Furthermore we will try to identify these factors that the PON1 acts on Beside plaques content and PON1s influence on them we would like to investigate the phenotype of haptoglobin in the subjects that the plaques were removed from It is known that diabetics that have the genotype haptoglobin 2-2 characterized by increased risk for oxygenation stress and cardiovascular events up to 5 times We would like to examine if there is a correlation between plaques content PON1s ability to disassemble oxygenized factors within the plaque and the phenotype to haptoglobin

Methods The plaque source will be from carotid endarterectomy in the vascular unit This procedure is a routine operation for patients suffering from carotid artery stenosis based on clinical decisions The plaques will be transported to a lipid laboratory soon after they will be harvested will be frozen in liquid nitrogen and processed into powder This material will be the origin for the proteins we try to extract Patients blood samples that is drawn routinely for the operation will be the source for the characterization of the haptoglobins genotype

It is critical to emphasize that routinely the plaques are waste products and only 5 cc of additional blood is withdrawn from the patients for research purposes

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None